gefitinib in treating patients with recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: biological therapies such as gefitinib may interfere with the growth of the tumor cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer. purpose: phase ii trial to study the effectiveness of gefitinib in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.

objectives: * determine the antitumor cytostatic activity of gefitinib, in terms of 6-month progression-free survival, in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma. * determine the nature and degree of toxicity in patients treated with this drug. * determine the partial and complete response rates in patients treated with this drug. * determine the duration of progression-free and overall survival in patients treated with this drug. outline: this is a multicenter study. patients receive oral gefitinib once daily. courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: approximately 22-60 patients will be accrued for this study within 1-2 years.

Eligibility criteria:
disease characteristics: * histologically confirmed ovarian epithelial or primary peritoneal carcinoma * recurrent or persistent disease * must have had prior therapy with no more than 1 platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease * platinum-resistant or refractory * treatment-free interval of less than 6 months after therapy with platinum-containing regimen or * progression during platinum-containing regimen or * platinum sensitive defined as treatment-free interval without disease progression for more than 6 months but less than 12 months after therapy with platinum-containing regimen * at least 1 lesion measurable in at least 1 dimension * at least 20 mm by conventional techniques (e.g., palpation, plain x-ray, ct scan, or mri) or * at least 10 mm by spiral ct scan * at least 1 target lesion outside a previously irradiated field * disease must be accessible to core needle biopsy * ineligible for higher priority gog protocol patient characteristics: age: * not specified performance status: * gog 0-2 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot no greater than 2.5 times uln * alkaline phosphatase no greater than 2.5 times uln renal: * creatinine no greater than 1.5 times uln cardiovascular: * no unstable cardiac disease * no myocardial infarction within the past 6 months * coronary artery disease, congestive heart failure, and dysrhythmia allowed if on stable regimen for at least 3 months other: * not pregnant * negative pregnancy test * fertile patients must use effective contraception * no sensory or motor neuropathy greater than grade 1 * no active corneal disease (e.g., keratoconjunctivitis) * no active infection requiring antibiotics * no evidence of bowel dysfunction that could be related to early bowel obstruction * no other invasive malignancy within the past 5 years except nonmelanoma skin cancer prior concurrent therapy: biologic therapy: * at least 3 weeks since prior immunological agents for the malignancy * no concurrent anti-cancer immunotherapy chemotherapy: * see disease characteristics * no more than 1 additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease * no prior noncytotoxic chemotherapy for recurrent or persistent disease * at least 3 weeks since prior chemotherapy for the malignancy and recovered * no concurrent anti-cancer chemotherapy endocrine therapy: * at least 1 week since prior anticancer hormonal therapy * concurrent hormone replacement therapy allowed * no concurrent anti-cancer hormonal therapy radiotherapy: * see disease characteristics * at least 3 weeks since prior radiotherapy for the malignancy and recovered * no prior radiotherapy to more than 25% of marrow-bearing areas * no concurrent anti-cancer radiotherapy surgery: * at least 4 weeks since prior surgery (except minor procedures under local anesthesia (e.g., central venous port placement)) and recovered other: * at least 3 weeks since other prior therapy for the malignancy * no prior gefitinib * no other prior epidermal growth factor receptor inhibitors * no prior anticancer therapy that would preclude study therapy * no concurrent chlorpromazine * no other concurrent investigational agents * no other concurrent antineoplastic agents * no concurrent cyp3a4-inducing agents, including phenytoin, carbamazepine, barbiturates, nafcillin, rifampicin, or st. john's wort

Keywords: recurrent ovarian epithelial cancer primary peritoneal cavity cancer